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Quviviq (DARIDOREXANT)
Quviviq works by blocking the action of orexin, a neurotransmitter that helps regulate sleep-wake cycles.
Quviviq (daridorexant) is a small molecule orexin receptor antagonist developed by IDORSIA PHARMACEUTICALS LTD and currently owned by Idorsia. It targets the orexin receptor type 1 to treat insomnia. Quviviq was FDA-approved in 2022 and is a patented medication with no generic manufacturers. Key safety considerations include its mechanism of action, which may affect sleep-wake cycles and other physiological processes. As a relatively new medication, long-term effects and potential interactions are still being studied.
At a glance
| Generic name | DARIDOREXANT |
|---|---|
| Sponsor | Idorsia |
| Drug class | Orexin Receptor Antagonist [EPC] |
| Target | Orexin receptor type 1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin and orexin to receptors OX1R and OX2R is thought to suppress wake drive.
Approved indications
- Insomnia
Common side effects
- Headache
- Somnolence or fatigue
- Dizziness
- Nausea
- Sleep paralysis
- Hypnagogic and hypnopompic hallucinations
- Sedation
- Lethargy
- Hypersomnia
- Vertigo
- Labyrinthitis
- Vomiting
Drug interactions
- Strong CYP3A4 inhibitors
- Moderate CYP3A4 inhibitors
- Strong or Moderate CYP3A4 inducers
- Alcohol and Other CNS Depressants
- CYP3A4 Substrates
- P-gp Substrates
Key clinical trials
- Dual Orexin Antagonism and Emotion and Affective Processing Study (PHASE4)
- Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms (PHASE4)
- Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder (PHASE3)
- Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking (PHASE4)
- Daridorexant to Prevent Post-cardiotomy Delirium (PHASE2)
- Daridorexant for Alzheimer Disease Prevention (PHASE2)
- Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Quviviq CI brief — competitive landscape report
- Quviviq updates RSS · CI watch RSS
- Idorsia portfolio CI